Defining Hydrolysates: An Approach for Generating a Chemically Defined Alternative

In the biopharmaceutical industry it is common to see protein hydrolysates in cell culture processes as part of a complete medium formulation or a fed-batch bioreactor process. It is well documented that hydrolysates can have a substantial positive impact on cell growth and/or protein production. However, given the undefined nature and the lot-to-lot variability associated with hydrolysates there exists a need to mitigate these risks with a chemically defined (CD) alternative that can maintain the desired performance. SAFC Biosciences® is now offering a new product that meets this goal and can quickly convert an undefined process to fully defined. The approach to solving this complex puzzle is discussed within, including details on how "active" hydrolysate fractions were found and the subsequent identification of the compounds contained within. The knowledge gained from this work was used to design EX-CELL® CD Hydrolysate Fusion, which is capable of replacing the functions of hydrolysates in many Chinese Hamster Ovary (CHO) cell systems.

Headquartered in Lenexa, Kansas, SAFC Biosciences is a leading provider of cell culture materials and development services for upstream and downstream processes in the biopharmaceutical industry. Providing an integrated services package in mammalian cell culture media development, along with analytical and regulatory support, SAFC Biosciences employs a wealth of industry experience and scientific know-how to deliver reliable, consistent solutions that accelerate customer success - from development through to commercialization.

The company has a 35-year history as a manufacturing partner providing leading biopharmaceutical companies with the broadest range of highly customized products and services possible. SAFC Biosciences has six production facilities in the United States, Europe and Australia, and employs 600 people.

We are focused on organizations involved in human therapeutics, animal health and diagnostics in various stages of development from pre-clinical through Phases I, II and III to commercialization. We have successful relationships with pharmaceutical, established biotech, start-up biotech and contract manufacturing organizations. SAFC Biosciences is the world's leading supplier of cell culture reagents to producers of marketed biological products.

Products/Services:

SAFC Biosciences' platforms include proprietary serum-free and classical media, sera and specialty products such as buffers, detachment factors, growth factors and protein components, supplements and reagents. We offer unique services related to small volume custom media as well as single-use disposable bioprocessing systems that provide upstream and downstream solutions for biologic processes.

Key to the SAFC Biosciences' offering is expertise in custom products and services, including development services for clone selection and optimization, cell culture media development and optimization, custom formulations and packaging.

We offer extensive regulatory, products and analytical support tied directly to customers' unique requirements. We have a proven track record in marketed biopharmaceuticals and are fully dedicated to customers' specific cell culture needs.

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